François-Xavier LeryGS1 HealthCare Conference
24 June 2010, Geneva
EDQM Track & Trace project
A Council of Europe Directorate, based on the Convention on the Elaboration of a European Pharmacopoeia (PA, 1964)
Mission: to contribute to a basic human right : access to good quality medicines and healthcare
European Directorate for the Quality of Medicines & HealthCare (EDQM)
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EDQM contribution -European Regulatory Network
• European Authorities• European Union
• Council of Europe
European Union
Council ParliamentCommission
DG Health and ConsumersBrussels
EuropeanMedicines Agency
EMA London
European Directoratefor the Quality
of Medicines & HealthCare
EDQMStrasbourg
Ph. Eur.
Certification
OMCLNetwork
Organ Transplantation
Blood Transfusion
PharmaceuticalsPharmaceutical care
Cosmetics/food packaging
Anti-Counterfeiting StrategiesMultiple actors / multifocal threat
Multi-level (“holistic”) strategy• Custom level (importation)• Legal instruments (pharmaceutical crime)• Pharmaceutical level
• Inspection• Testing – evidence for enforcement• Packaging (traceability of serialised items)
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The Beatles4381439
Mass serialisation: current situation
• EU Pharma package under discussion• Existing or on-going development of
Track & Trace national systems at item level in Belgium, Italy, Greece, Spain, Germany, Ireland + Turkey Serbia – Batch level in France– EFPIA pilot study in Sweden
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Main features of systems existing or under development
• From manufacturer to Point of Dispensing = “end-to-end” (exc. pilots in DE and ES)
• No coverage of Internet sales • Developed bottom-up from community
pharmacies or top-down from manufacturers• No interoperability / different standards &
data carriers (no GS1 standards in BE GR IT)• Expansion country by country
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EU Pharma package
• EC proposed amended Dir 2001/83/EC on prevention of the entry into the legal supply chain of falsified medicinal products – safety features make possible to ascertain
identification, authenticity and traceability of medicinal products
– shall allow wholesale distributors or pharmacists to identify individual packs
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Current situation: End-to-end solutions
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Generationof item code
Verificationat dispensing point
Manufacture Distribution Retail pharmacy
Proposed EDQM Track & Trace Solution
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10
Generationof UMI Tracing & Verification of UMI
Manufacture- Distribution- Pharmacies
Governance: EDQM as a intergovernmental organisation guaranteeing sustainable confidentiality of data
Verificationof UMI
Patients- Internet/mail-order pharmacies
EDQM Project: Track & Trace Service
• Mass serialisation with UMI = Unique Medicine Identifier per item
• UMI unique, unbreakable and interoperable with other existing systems (e.g.: by using GS1 standard)
• Data carrier: – Human-readable number– Barcode (state-of-the-art = Datamatrix)– Need for flexibility to accommodate other suitable
technologies (e.g.: RFID in the future)• Query to EDQM Track & Trace Service to verify existence of
UMI to a directory of EPCIS repositories (Electronic Product Code Information System GS1 standardised)
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Directory vs. Repository
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1 - Manufacturers uploading their UMIs
UMI Queries: Pharmacies, patients, customs etc.
Track & Trace Service for Medicines
Cap
ture
Ser
vice Q
uery ServiceDirectory Service
(Rules Engine)
2 – Manufacturers with own UMI repositories
Scope of the Project (1 of 3)
• Any Pharmaceutical products on a voluntary basis
• Any registered business stakeholders within distribution
• Patients• Authorities
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Scope of the Project (2 of 3)
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All 36 member states of the European Pharmacopoeia and beyond if interested (observers?)
Scope of the Project (3 of 3)
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Manufacturers/Innovators
Logistic service provider
(i.e. wholesaler)
Pharmacies(Physical /Online)
PatientsHospitals
Bundle
Secondary packaging
(e.g.: folding box, bottle)
Primary packaging
(e.g.: Blisters)
Current scope
Possible additional scope
Pallet
Dosage form(e.g.: tablets)
Case
General Overview on Project
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Phase 1Concept
development
Phase 2Live demo
Phase 3Service
development
Dec 09-March 2010 Apr 2010 – 2Q11 From Q3 2011
Alignment with stakeholders and user and business requirements
Unique Medicine Identifier: no new or proprietary standards
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• UMI will use GS1 GTIN or ‘NTIN’• Use of the AI (application identifiers)
– Product code– Serial number– Expiry date– Batch number
• Use of GLN or DUNS for business actors
©2010 EDQM, Council of Europe, All rights reserved
UMI using national code (no GTIN or NTIN)
example UMI with national code
• Allows the integration of national product codes – EDQM specific application identifier ?– 3-digit country code following the GS1 standards
for country codes– national code (e.g. in Germany 7 digit PZN)– variable length but maximum 20 digits
“Core” – Product codes registration interface
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• Product code registration interface:– Integration of product
code data imported from national organisations (e.g. IFA in Germany)
– GTIN linked with PZN (non-GTIN DE code) in IFA DB
– Integration of product codes sent by the manufacturers before sending the UMIs
• Multiplicity of coding format:– will require higher investment costs from manufacturers
(inline packaging) – Cost passed on to other parties (patients / health insurance)
• Governance– Procedures for alerting authorities without delay in case of
detection / suspicion of counterfeiting• Trusted third party (not a service provider)
establishing/managing them– Repositories architecture
• Network of decentralised repositories vs. centralised repository
National schemes vs. pan-European scheme
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Alignment with GS1 standard EPCIS
• EPCIS = Electronic Product Code Information Service– communication standard to ensure interoperability
among the actors – EPCIS specifies standard data sharing interface
• Types of required communication messages– EPCIS communication messages contain events– Events typically generated by an EPCIS capturing
application
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Summary and Outlook• Users and business requirement phase completed
mid March 2010• Phase 2 (live demo development) start Q2 2010• Along Phase 2 EDQM will
– keep interacting with relevant stakeholders, partners for live demo (ERP, WMS, POS, associations of stakeholders)
– Validating exhaustively country by country technical options taken (business cases)
• Live demo used a proof of concept to rally support of stakeholders for phase 3 (system development) and 4 (phased implementation and deployment)
©2010 EDQM, Council of Europe, All rights reserved24
Contact details:Francois-Xavier Lery
EDQM - Department for Biological Standardisation, OMCL Network and
HealthCare (DBO)Email: [email protected]
Tel: +33 (0) 3 88 41 33 62